In Merck KGaA v. Integra LifeSciences I Ltd., the U.S. Supreme Court adopted a broad construction of the regulatory approval exception to patent law infringement, 35 U.S.C. § 271(e)(1), for experiments conducted at early stages of the pharmaceutical development process. But the Court refused to determine whether that exception applies to patented “research tools,” and failed to address the relationship of that exception to the historic experimental use exception. The U.S. Court of Appeals for the Federal Circuit has narrowly construed the experimental use exception, but also refused in its recent decision on remand in Merck to resolve these questions, leaving in place substantial disagreements over the nature and scope of the exceptions that were reflected in its earlier decision (which the Supreme Court reversed). In contrast to the substantial uncertainties in American patent law, European experimental and regulatory approval exceptions may be subject to somewhat fewer interpretive uncertainties, particularly in light of decisions such as the U.K. Monsanto and German Klinische Versuche (Clinical Trials) cases. But the nature and scope of the European exceptions nevertheless may be subject to dispute and may vary significantly among jurisdictions based on national legislative decisions to limit or extend patent protection, such as the recent Belgian law adopting an experimental use exception that expressly applies to patented research tools.

Determining the proper scope and application of experimental use and regulatory approval exceptions remains a pressing concern. These exceptions assure that patent laws intended to provide incentives for technological innovation do not unduly restrict scientific research, innovative medical product development and generic product competition. The social harms that can result from narrow exceptions have been emphasized by the Merck decision, by the recent (initial) invalidation of restrictively licensed stem-cell patents, and by empirical studies that suggest that valid patents may (in light of the narrow construction that has been given to the experimental use exception in the U.S.) increasingly delay or restrict scientific research. However, the scope of these exceptions remains highly controversial, particularly for biotechnological research tool inventions for which capital investments and market returns may depend upon the ability to prevent such unlicensed research uses.

In this article, we provide a comparative analysis of the history and current state of the experimental use and regulatory approval exceptions under U.S. and European laws. We explore the application of these exceptions to research tools in academic and commercial sectors, distinguishing research on an invention from research with it, discussing potential differences of treatment among the exclusive patent rights, and noting the arguments for extending or restricting the exceptions. We also discuss relevant constitutional and international treaty-law considerations for legislative and judicial policymaking. We conclude with a dialog that seeks to provide guidance for lawmakers, by identifying relevant questions that will need to be answered in order to resolve the appropriate scope of experimental use and regulatory approval exemptions.